Quality Engineer - Medical Device Components - Burlington MA

Burlington Permanent USD70,000 - USD85,000
  • Work with a world leader of precision metal manufacturing and medical specialist
  • Terrific team culture with an emphasis on internal growth

About Our Client

My client is a world leader in precision metal manufacturing. With unparalleled experience in high-precision manufacturing, my client provides a full spectrum of Manufacturing Solutions and Services in the countless areas.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

The Quality Engineer will be responsible for:

  • Maintain applicable quality systems, environmental, and FDA requirements/certifications.
  • Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
  • Proficient in full and proper Geometric Dimensioning & Tolerancing (GD&T) application, and blueprint reading.
  • Determine/improve inspection methods/instructions and incorporate them into the manufacturing processes and Inspection Plans.
  • Generate applicable quality metric reports; cost of quality, management by facts.
  • Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
  • Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem solving techniques.
  • Works with Engineering to conceptualize and develop gauging. Applies basic statistical and Six Sigma concepts and techniques.
  • Maintain knowledge of all procedures, changes to specifications and new regulations related to areas of responsibility.

The Successful Applicant

The successful Quality Engineer will have the following:

  • Bachelor's degree with engineering focus preferred or equivalent combination of education and experience
  • 3 plus years' experience in quality within medical device manufacturing or Automotive industry, preferred.
  • ISO 13485, CAPA, Validations and customer interaction experience required.
  • Six Sigma Black belt certification, preferred
  • Manufacturing Operations - machining and/or forging
  • Regulations - FDA, GMP and ISO Regulations
  • Metrology
  • Must be able to read and interpret engineering drawings, ANSI-Y-14.5 dimensioning and tolerancing
  • Knowledge of ANSI-Z1.4 and 1.9 lot sampling

What's on Offer

In return, the Quality Engineer should expect:

  • Competitive salary and benefits
  • Excellent leadership dedicated to internal growth
  • 401k match
  • New facility focusing on growth



Please reach out to Cameron Cyker with any questions. All qualified candidates can expect feedback within 48 hoursApply below today

Contact
Cameron Cyker
Quote job ref
JN-012022-4574116

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industry
Industrial / Manufacturing
Location
Burlington
Contract Type
Permanent
Consultant name
Cameron Cyker
Job Reference
JN-012022-4574116